The present invention relates to improved methods and devices for bone augmentation.
Treatment of edentulous patients with osseointegrated fixtures made of titanium is a well known procedure in the art. The procedure includes installing a fixture in the alveolar bone of an at least partially edentulous jaw. Usually several months are required for proper healing after fixture installation.
After healing, an abutment is installed on the upper portion of the fixture. After several weeks, an artificial tooth may be mounted on the abutment and the procedure is complete.
Installation of implants requires sufficient alveolar bone, generally about 10 mm height and 6 mm width.
When a tooth is removed, the alveolar bone is gradually resorbed because of the absence of stimulus of ossification-inducing pressure from the teeth. As the resorption process advances, the size of the bone gets reduced, i.e. the bone on which the dental roots are positionedxe2x80x94the alveolar ridge start shrinking.
The absence of just one tooth can cause modifications throughout the dental arch and even prompt a possible softening (loss of insertion) which may cause the loss of other teeth. The absence of several teeth aggravates the problem. Bone loss may finally modify the patient""s appearance and, depending on the loss, may make him incapable of receiving bridges, implants or even dentures.
It is then necessary to carry out several surgical operations to reconstruct the alveolar ridge of the maxilla or mandible.
Although these methods of surgical reconstruction have been successfully performed, this type of operation has had drawbacks. Certain methods have involved opening the periosteal tissue (which is the tissue surrounding the bone and is easily detached from the bone) along the entire length of the atrophic alveolar ridge and then placing a bone graft material and a membrane on top of the graft and then suturing the delicate periosteal tissue back together to cover the membrane. The role of the membrane is to maintain the bone graft in its place and to prevent the mucoepithelium from growing into the graft and interfering with the process of bone regeneration. This surgical operation called guided bone regeneration has had drawbacks resulting from the lack of enough soft tissue to cover the enlarged bone.
In order to overcome some of these drawbacks, another small surgical procedure is done before the performance of the procedures mentioned above. In this procedure an expandable device is placed beneath the periosteum through a small incision. This device made of silicon is gradually filled with a liquid through a cannula. While this expandable device expands tension is transferred to the periosteum leading to enlargement of the periosteum. When the periosteum reached the desired dimension the expandable device is taken out and a bone graft is placed as described above, but now there is no need to stretch the mucoperiosteal tissue therefor reducing the complications.
This procedure has two significant drawbacks:
1. Two surgical procedures are needed. A small procedure for insertion of the expandable device and a big procedure for placing the bone graft and the membrane.
2. All the hazards of a relative big operation in the mouth.
Another method to regenerate bone is distraction osteogenesis, which is a process whereby bone is stretched to increase bone volume. According to distraction osteogenesis processes, at least one portion of a bone is at least partially separated from the bone. The position of the portion is gradually altered with respect to the bone. Time is then provided for new bone to fill in the space between the portion and the overall bone.
When distraction osteogenesis is used in dentistry dental applications, a portion of a patient""s jawbone will be at least partially severed from the overall jawbone. The jawbone segment may then be gradually separated from the rest of the jawbone. New bone then fills in the space between the segment and the jawbone. By increasing the volume of bone in the jawbone, additional area can be provided to anchor or at least more securely anchor dental implants. Distraction osteogenesis can also be used in dental applications simply to strengthen a location on the jawbone to increase the bone volume at that location even if implants are not to be secured in the jawbone at that location. These techniques of distraction osteogenesis has some disadvantages:
1) It is difficult technically to the surgeon.
2) It is traumatic to the patient.
3) This procedure can be done if the height of the ridge is at least 6 mm
4) This technique is not using the new materials available today that enhance bone regeneration.
The present invention is unique because these methods and devices allow distraction osteogenesis without cutting a segment of the bone therefore the procedure is simple minimal invasive and not traumatic. In the present invention only the periosteal tissue is separated from the bone. In another embodiment of the invention materials that enhance bone regeneration can be added to the distraction gap.
The present invention provides a method and device to regenerate bone. The device is preferably made from a plate placed subperiostealy and a force inducing mechanism to allow gradual displacement of the periosteal tissue from the bone. The device can be made fully or partially of a bioresorbable material.
The device is activated one or more times every few days till the desired enlargement is reached. While the plate moves it conducts tensile forces to the surrounding tissue, which reacts in proliferation and enlargement. The gap between the plate and the bone is filled with bone callus if the periosteal tissue is displaced slowly. At the same time bone substitute materials can be added through a filling element. After the desired enlargement is reached the filling element can be pull out if necessary. The end result is a new or an enlarge compartment in the body filled with new bone callus and bone substitute materials.
The insertion of the device can be through a small incision to a subperiosteal tunnel so all the process is done with almost no surgery.
There are many possible implementations of the device and method depending on several factors:
1. The place the device is inserted into.
2. The filling material.
3. The shape of the plate.
4. The kind of filling element that is in use.
5. The kind of material the plate is made of.
The devices and methods are particularly useful for plastic surgery, orthopedic surgery and, dental implantology.
Other objects and features of the present invention will become apparent in the following detailed description when taken in connection with the accompanying drawings which disclose one embodiment of the invention. It is to be understood that the drawings are designed for the purpose of illustration only and are not intended as a definition of the limits of the invention.
Thus, according to the teachings of the present invention there is provided, a method for expanding, stretching or displacing bone tissue comprising: (a) inserting subperiostealy at least part of a displacing device comprising a movable subperiosteal element and a force inducing mechanism configured after activation so as to move the movable subperiosteal element; the movable subperiosteal element is configured after activation of the force inducing mechanism so as to induce forces displacing at least part of the periosteal tissue. (b) activating said force inducing mechanism.
According to a further feature of the present invention the activation is performed in a plurality of stages separated by at least a number of hours, each stage incrementally displacing the periosteal tissue.
According to a further feature of the present invention, the displacing is done continuously over a period of time.
According to a further feature of the present invention, the speed of the displacing of the periosteal tissue is appropriate for formation of bone callus between the bone tissue and the periosteal tissue.
According to a further feature of the present invention, the force inducing mechanism induces forces continuously.
According to a further feature of the present invention, the force inducing mechanism is a pump.
According to a further feature of the present invention, the force inducing mechanism is pressure beneath the movable subperiosteal element.
According to a further feature of the present invention, the activation is done by introducing a biocompatible filling material beneath the movable subperiosteal element.
According to a further feature of the present invention, the displacing is combined with introducing a biocompatible filling material beneath the movable subperiosteal element.
According to a further feature of the present invention, the biocompatible filling material includes material for promoting the growth of bone.
According to a further feature of the present invention, the biocompatible filling material includes material for promoting the growth of bone.
According to a further feature of the present invention, the displacing device includes a filling conduit partially inserted into the tissue.
According to a further feature of the present invention, the filling conduit includes a one-directional valve.
According to a further feature of the present invention, the filling conduit includes a sealing means for sealing the filling conduit.
According to a further feature of the present invention, the method further comprising introducing disinfecting material into the filling conduit.
According to a further feature of the present invention, the filling conduit includes at least one fixation component configured to allow fixation of the filling conduit to the tissue.
According to a further feature of the present invention, the displacing device is formed at least in part from a bio-dissipative material.
According to a further feature of the present invention, the displacing device is formed at least in part from a self-expanding material.
According to a further feature of the present invention, the displacing device is configured to influence the direction of displacement of the periosteal tissue as the displacing device is activated.
According to a further feature of the present invention, the displacing device is configured to prevent displacement of the periosteal tissue not in the direction.
According to a further feature of the present invention, the displacing device is configured to take a specific shape as the force inducing mechanism is activated.
According to a further feature of the present invention, the displacing device is configured to grow in a telescopic pattern.
According to a further feature of the present invention, the displacing device is formed at least in part from a stretchable material.
According to a further feature of the present invention, at least part of the periosteal tissue is covered by a rigid structure so as to guide the periosteal tissue to take the shape of the rigid structure as the periosteal tissue is displaced.
According to a further feature of the present invention, the displacing device is formed with at least one fixation feature.
According to a further feature of the present invention, the displacing device is glued to the tissue.
According to a further feature of the present invention, the displacing device is inflatable.
According to a further feature of the present invention the displacing device becomes inflatable after insertion subperiostealy.
According to a further feature of the present invention, the activating is done by turning a screw.
According to a further feature of the present invention, the activating is done by taking an inhibiting component out.
According to a further feature of the present invention, the activating is done by allowing a bio-dissipative inhibiting component to disperse.
According to a further feature of the present invention, the force inducing mechanism comprising magnetic forces.
According to a further feature of the present invention, the movable subperiosteal element is formed at least in part from a magnetic material.
According to a further feature of the present invention, the movable subperiosteal element is enclosed in a biocompatible casing.
According to a further feature of the present invention, the activating is done outside the tissue. According to a further feature of the present invention, the activating is done inside the tissue.
According to a further feature of the present invention, the force inducing mechanism comprising forces induced by turning a screw.
According to a further feature of the present invention, the screw is hollow and perforated.
According to a further feature of the present invention, the force inducing mechanism comprising a compressed element trying to become not compressed.
According to a further feature of the present invention, the compressed element comprising a coil.
According to a further feature of the present invention, the activation is made by a biocompatible material enclosed in a bio-dissipative casing; the biocompatible material becomes active after the casing starts to disperse.
According to a further feature of the present invention, the activation is made by temperature changes.
According to a further feature of the present invention, the movable subperiosteal element is configured so as to allow passage of materials from the periosteal tissue.
According to a further feature of the present invention, the device is configured to allow passage of materials between the exterior space of the device and the interior space of the device.
According to a further feature of the present invention, the displacing device comprising a reference element and the force inducing mechanism induces forces between the reference element and the movable subperiosteal element.
According to a further feature of the present invention, the reference element is fixated to the bone.
According to a further feature of the present invention, the reference element is a bone implant.
According to a further feature of the present invention, the reference element is connected to the movable subperiosteal element by a hinge.
According to a further feature of the present invention, the hinge configured as to allow movement only in one direction.
According to a further feature of the present invention, the reference element is fixated to a tooth.
According to a further feature of the present invention, the reference element is fixated to a dental prosthesis.
According to a further feature of the present invention, the reference element is formed at least in part from magnetic material.
According to a further feature of the present invention, the reference element is gradually displaced.
According to a further feature of the present invention, the reference element includes a ball socket and the force inducing mechanism includes a screw with a ball at its edge; the ball is configured to fit inside the ball socket forming a joint so as to allow control on the position of the screw.
According to a further feature of the present invention, the force inducing mechanism includes forces induced by manual pulling.
According to a further feature of the present invention, the displacing device is a double sheet concave balloon.
According to a further feature of the present invention, the displacing device is configured so as to prevent movement of the movable subperiosteal element towards the bone.
According to a further feature of the present invention, at least part of the displacing device is configured to be pulled out easily from the tissue.
According to a further feature of the present invention, further comprising, prior to inserting the part of the displacing device, forming a subperiosteal tunnel for insertion of the part of the displacing device.
According to a further feature of the present invention, after insertion of the part of the displacing device inside the tunnel, forming a hole in the periosteal tissue above the part of the displacing device and allowing part of the displacing device to protrude above the periosteal tissue.
According to a further feature of the present invention, after insertion of the part of the displacing device inside the tunnel, forming a hole in the periosteal tissue above the part of the displacing device and connecting part of the displacing device to protrude above the periosteal tissue.
According to a further feature of the present invention, the movable subperiosteal element includes a fixation element configured to attach the movable subperiosteal element to the periosteal tissue.
According to a further feature of the present invention, the fixation element is in the shape of an arrow.
According to a further feature of the present invention, the displacing device is used to stabilize a denture.
There is also provided according to the teachings of the present invention, a device for expanding, stretching or displacing bone tissue comprising: a biocompatible movable subperiosteal element for insertion subperiostealy and a force inducing mechanism configured after activation so as to displace the movable subperiosteal element; the movable subperiosteal element is configured after activation of the force inducing mechanism so as to induce forces displacing at least part of the periosteal tissue.
According to a further feature of the present invention, the device is configured to allow the activation to be performed in a plurality of stages separated by at least a number of hours, each stage incrementally displacing the movable subperiosteal element.
According to a further feature of the present invention, the device is configured to allow continuous displacing of the movable subperiosteal element.
According to a further feature of the present invention, the speed of the displacing of the movable subperiosteal element is appropriate for formation of bone callus between the bone tissue and the periosteal tissue.
According to a further feature of the present invention, the force inducing mechanism is a pump.
According to a further feature of the present invention, the device is formed at least in part from a bio-dissipative material.
According to a further feature of the present invention, the device is formed at least in part from a self-expanding material.
According to a further feature of the present invention, the device is configured so as to influence the direction of displacement of the periosteal tissue as the displacing device is activated.
According to a further feature of the present invention, the device is configured to prevent displacement of the periosteal tissue not in the direction.
According to a further feature of the present invention, the device is configured to take a specific shape as the force inducing mechanism is activated.
According to a further feature of the present invention, the device is configured to grow in a telescopic pattern.
According to a further feature of the present invention, the device includes a filling conduit configured for insertion of material beneath the movable subperiosteal element; the filling conduit configured so as to be accessible from outside the periosteal tissue.
According to a further feature of the present invention, the filling conduit includes a one-directional valve.
According to a further feature of the present invention, the filling conduit includes a sealing means. According to a further feature of the present invention, the filling conduit is comprising a chamber for receiving disinfecting material.
According to a further feature of the present invention, the filling conduit includes at least one fixation component configured to allow fixation of the conduit to the tissue.
According to a further feature of the present invention, the device is formed with at least one fixation feature.
According to a further feature of the present invention, the device is inflatable.
According to a further feature of the present invention, the device is configured so as to becomes inflatable after insertion subperiostealy.
According to a further feature of the present invention, the movable subperiosteal element is configured so as to allow passage of materials from the periosteal tissue.
According to a further feature of the present invention, the device is configured to allow passage of materials between the exterior space of the device and the interior space of the device.
According to a further feature of the present invention, the device is formed at least in part from a stretchable material.
According to a further feature of the present invention, the device is configured so as to be glued to the tissue.
According to a further feature of the present invention, the force inducing mechanism is configured so as to induce force by turning a screw.
According to a further feature of the present invention, the screw is hollow and perforated.
According to a further feature of the present invention, the device includes an inhibiting component configured to prevent activation of the force inducing mechanism.
According to a further feature of the present invention, the inhibiting component configured so as to be taken out.
According to a further feature of the present invention, the inhibiting component is a wire.
According to a further feature of the present invention, the inhibiting component is formed at least in part from a bio-dissipative material.
According to a further feature of the present invention, the movable subperiosteal element is formed at least in part from a magnetic material.
According to a further feature of the present invention, the movable subperiosteal element is enclosed in a biocompatible casing.
According to a further feature of the present invention, the force inducing mechanism comprising magnetic forces.
According to a further feature of the present invention, the force inducing mechanism comprising a compressed element trying to become not compressed.
According to a farther feature of the present invention, the compressed element includes a coil.
According to a further feature of the present invention, the force inducing mechanism includes a material that change its shape by temperature changes.
According to a farther feature of the present invention, the device includes a reference element and the force inducing mechanism configured so as to induces forces between the reference element and the movable subperiosteal element.
According to a further feature of the present invention, the reference element is configured so as to be fixated to the bone.
According to a further feature of the present invention, the reference element is a bone implant.
According to a further feature of the present invention, the reference element is connected to the movable subperiosteal element by a hinge.
According to a further feature of the present invention, the hinge configured as to allow movement only in one direction.
According to a further feature of the present invention, the reference element is configured so as to be fixed to a tooth.
According to a further feature of the present invention, the reference element is configured so as to be fixed to a dental prosthesis.
According to a further feature of the present invention, the reference element is formed at least in part from a magnetic material.
According to a further feature of the present invention, the reference element is configured so as to be gradually displaced.
According to a further feature of the present invention, the reference element includes a ball socket and the force inducing mechanism includes a screw with a ball at its edge; the ball is configured to fit inside the ball socket forming a joint so as to allow control on the position of the screw.
According to a further feature of the present invention, the device is a double sheet concave balloon.
According to a further feature of the present invention, the device is configured so as to prevent movement of the movable subperiosteal element towards the bone.
According to a further feature of the present invention, at least part of the displacing device is configured so as to be pulled out easily from the tissue.
According to a further feature of the present invention, the device includes a protruding element configured so as to be connected to the device after insertion subperiostealy and protrude outside the tissue.
According to a further feature of the present invention, the protruding element is configured to allow connection to other elements.
According to a further feature of the present invention, the protruding element is configured to allow introducing of materials beneath the movable subperiosteal element.
According to a further feature of the present invention, the movable subperiosteal element includes fixation element configured so as to attach the movable subperiosteal element to the periosteal tissue.
According to a further feature of the present invention, the fixation element is in the shape of an arrow.
According to a further feature of the present invention, the device includes an active biocompatible material enclosed in a bio-dissipative casing.